Deep Sclerectomy Versus Trabeculectomy in Normal Tension Glaucoma

Not Applicable

Recruiting

• Conditions: Normal Tension Glaucoma
• Interventions: Procedure: Trabeculectomy; Procedure: Deep Sclerectomy

• Registration Number: NCT05371977
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

The purpose of this study is to assess whether deep sclerectomy is as effective in lowering intraocular pressure (IOP) as trabeculectomy in patients with normal tension glaucoma.

Detailed Description

Subjects with normal tension glaucoma that is unstable with current medication needing filtration surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having deep sclerectomy or trabeculectomy.

Study Timeline

• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-12
• Study Start: 2022-05-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Signed Informed Consent
• Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
• Glaucoma unstable with current medication assessed by a glaucoma specialist

Exclusion Criteria

• Secondary Glaucoma e.g. due to previous injury or uveitis
• Exfoliation syndrome
• Pigment dispersion syndrome
• Previous transscleral or endoscopic cyclophotocoagulation
• Previous other glaucoma surgery
• Previous retinal detachment
• Previous intraocular surgery like vitrectomy and other retinal surgery
• Wet age-related macular degeneration
• Diabetic retonopathy
• Previous corneal transplant or previous refractive surgery
• Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars
• The patient does not want to participate in the study
• The patient does not speak Finnish, Swedish or English
• Dementia
• Only eye with vision worse than 20/200 or loss of central visual field

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trabeculectomy	Trabeculectomy	-
Deep sclerectomy	Deep Sclerectomy	-

Primary Outcome Measures

Name	Time	Method
Success Rate	One year	Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications

Secondary Outcome Measures

Name	Time	Method
Success Rate	5 years	Decrease in Intraocular Pressure of 20 % or more or former level with fewer medications

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland